Quality assurance of pharmaceuticals: a compendium of guidelines and related materials • Tenth Edition • Volume 2

QA, however, should be validated. The guide as a whole does not cover safety aspects
for the personnel engaged in manufacture, or environmental protection: these are
normally governed by national legislation. A new concept of hazard analysis related
to the risks in production and personnel safety has also been recently recommended
(WHO Technical Report Series, No. 961, Annex 7). The manufacturer should assure the
safety of workers and take the necessary measures to prevent pollution of the external
environment.
International Nonproprietary Names (INN) for pharmaceutical substances
designated by WHO should be used when available, together with other designated
names.

Glossary
The definitions given below apply to the terms used in this guide. They may have different
meanings in other contexts.
active pharmaceutical ingredient (API). Any substance or mixture of
substances intended to be used in the manufacture of a pharmaceutical dosage form
and that, when so used, becomes an active ingredient of that pharmaceutical dosage
form. Such substances are intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect
the structure and function of the body.
airlock. An enclosed space with two or more doors, which is interposed between
two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling
the airflow between those rooms when they need to be entered. An airlock is designed
for use either by people or for goods and/or equipment.
authorized person. The person recognized by the national regulatory authority
as having the responsibility for ensuring that each batch of finished product has
been manufactured, tested and approved for release in compliance with the laws and
regulations in force in that country.
batch (or lot). A defined quantity of starting material, packaging material,
or product processed in a single process or series of processes so that it is expected
to be homogeneous. It may sometimes be necessary to divide a batch into a number
of sub-batches, which are later brought together to form a final homogeneous batch.
In the case of terminal sterilization, the batch size is determined by the capacity of
the autoclave. In continuous manufacture, the batch must correspond to a defined
fraction of the production, characterized by its intended homogeneity. The batch size
can be defined either as a fixed quantity or as the amount produced in a fixed time
interval.
batch number (or lot number). A distinctive combination of numbers and/or
letters which uniquely identifies a batch on the labels, its batch records and corresponding
certificates of analysis, etc.

14